BENEFITS OF THE ALL IN ONE MDSAP AUDIT MODEL

According to the FDA, the MDSAP pilot audit was developed to cover existing requirements from the regulatory authorities participating in the MDSAP Pilot in order to facilitate an all in one audit.

Apart from the existing requirements by the ISO13485: 2016 and the medical device regulations from the participating regulatory authorities the program does not include any further requirements.

The audit incorporates the following

• ISO 13485: 2016 – Medical devices Quality management systems; Requirements for regulatory purposes
• Quality System Regulation (21 CFR Part 820)
• Brazillian Good Manufacturing Practices (RDC ANVISA 16/2013)
• Licensing, Registration, Advisory notices as well as other specific requirements as medical device regulatory authorities participating in the MDSAP pilot program.

MANUFACTURERS BENEFITS OF PARTICIPATING IN MDSAP PILOT

In the United States, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health allow the use of the MDSAP Pilot report as a suitable alternative for the FDA routine inspections.

Furthermore, the certification documents issued by the auditing organization communicate compliance with applicable US regulations which may provide a marketing advantage.

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MDSAP PILOT GOALS AND FUTURE MDSAP USE